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LEVITRA Drug Profile

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Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and forty-three patent family members in fifty-two countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for LEVITRA

International Patents:	143
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	4
Bulk Api Vendors:	131
Clinical Trials:	24
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LEVITRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVITRA
DailyMed Link:	LEVITRA at DailyMed

Pharmacology for LEVITRA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for LEVITRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No			Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No			Y	Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003	AB	RX	Yes	No			Y	Y

Expired US Patents for LEVITRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003

Paragraph IV (Patent) Challenges for LEVITRA

Drugname	Dosage	Strength	RLD	Date
	Tablets	2.5 mg
	Tablets	5 mg ad 10 mg
	Tablets	20 mg

International Patents for LEVITRA

Country	Patent Number	Estimated Expiration
Norway	335434
Brazil	0305559
Israel	166162
Hungary	230154
World Intellectual Property Organization (WIPO)	9924433